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FDA Drug Import News

Import Rules Regarding Personal Medicine Orders:

Current FDA policy is not a law or a regulation, but serves as guidance for FDA personnel.

The importation of certain unapproved prescription medications for personal use may be allowed in some circumstances where these factors apply:


    1). The Drug is for personal use and is a 3-month supply or less and not for resale or commercialization.

    2). If no drug commercialization or drug promotion to U.S. residents by pharmacy companies involved in the distribution of the necessary drug exists.

    3). If an individual seeking to import the drug affirms in writing, that it is for the patient's private use and provides the name and address of the licensed American physician responsible for treatment.

    4). Provides evidence that the drug is for continuation of a treatment begun in a foreign country.

    5). The intended use is for a serious condition for which effective treatment may not be available domestically.

    6). If the product is not considered to represent an unreasonable health issue.

    7). Overnite FedEx shipments require copy of your identification and the prescription.

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Rx News

Vincristine-Generic, Oncovin 1mg

Vincristine-Generic, Oncovin 1mg
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Price: $35.00
Product ID : oncovin
Manufacturer: SANDOZ
Shipping Price: $25.00
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Min/Max Order: 1 / 500

Description

Oncovin (vincristine sulfate)

Pronunciation: (vin-KRISS-teen)
Class: Vinca alkaloid Trade Names: Oncovin - Solution for Injection 1 mg/mL.

Indications and Usage

Adult/Pediatric

Acute lymphocytic leukemia, lymphomas, rhabdomyosarcoma, neuroblastoma, Wilms tumor.

Dosage and Administration

Acute Lymphocytic Leukemia, Lymphomas, Rhabdomyosarcoma, Neuroblastoma, Wilms Tumor
Adult

IV 1.4 mg/m 2 weekly (typical dose, 2 mg).

Children weighing more than 10 kg (or body surface area at least 1 m 2 )

IV 1.4 to 2 mg/m 2 weekly for 3 to 8 wk. Do not exceed a max of 2 mg/dose.

Children weighing up to 10 kg (or body surface area less than 1 m 2 )

IV 0.05 mg/kg weekly initially. Titrate dose as tolerated, up to a max of 2 mg/dose. Continue therapy for 3 to 8 wk.

Adjustment in Hepatic Insufficiency
Adult

IV A 50% reduction in dose is recommended for patients having a direct serum bilirubin value more than 3 mg/dL.

Neuroblastoma, Combination Therapy
Children weighing more than 10 kg (or body surface area at least 1 m 2 ) IV Vincristine 1 mg/m 2 /day by continuous infusion over 24 h for 3 days (total dose of 3 mg/m 2 over a 3-day perio

Unlabeled Uses

Small-cell lung carcinoma, brain tumors, multiple myeloma, Kaposi sarcoma, chronic lymphocytic and myelocytic leukemias, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura.

Caution–This preparation should be administered by individuals experienced in the administration of Vincristine Sulfate Injection, USP. It is extremely important that the intravenous needle or catheter be properly positioned before any Vincristine is injected. Leakage into surrounding tissue during intravenous administration of Vincristine Sulfate Injection, USP may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis.

FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY


Contraindications

Patients with demyelinating form of Charcot-Marie-Tooth syndrome.

 

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